Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Meghna Alimchandani, MD
Deputy Director
Division of Pharmacovigilance (DPV)
Office of Biostatistics and Pharmacovigilance (OBPV)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Meghna Alimchandani, MD, serves as the Deputy Director of the Division of Pharmacovigilance (DPV), Office of Biostatistics and Pharmacovigilance (OBPV) at FDA’s Center for Biologics Evaluation and Research (CBER), where her work focuses on pharmacovigilance planning, and passive and active postmarketing safety surveillance for products regulated by the Center. She supervises DPV staff in pharmacovigilance plan reviews for Biologics License Application (BLAs), including original submissions and supplements. The pharmacovigilance review encompasses evaluation of safety-related postmarketing requirement/commitment (PMR/PMC) studies, Risk Evaluation and Mitigation Strategy (REMS), and spontaneous adverse event data.
She joined FDA in 2014 as a medical officer in DPV, OBPV and her past roles have included serving as the Branch Chief in DPV, and Associate Director in OBPV. She also gained experience in regulatory review of investigational biologics and clinical trial data while serving as a medical officer in the Office of Tissues and Advanced Therapies (now Office of Therapeutic Products) in CBER. Prior to FDA, Dr. Alimchandani received her medical degree from the Albert Einstein College of Medicine of Yeshiva University, Bronx, NY and completed her residency in Anatomic Pathology at the National Institutes of Health, Bethesda, MD.
Abstract
Meghna Alimchandani from CBER’s Office of Biostatistics and Pharmacovigilance at the FDA discusses postmarketing safety surveillance for regulated products, with a particular focus on product safety during pregnancy. She highlights that surveillance after a product is licensed is crucial because premarket clinical trials often have limitations, such as excluding vulnerable populations like pregnant women, limited sample sizes, and shorter observation periods, which may not detect rare or long-latency adverse events. The presentation outlines key postmarketing strategies, including passive surveillance based on spontaneous and mandatory adverse event reporting to databases like VAERS and FAERS, and active surveillance, primarily through post approval pregnancy safety studies. These studies can be prospective pregnancy registries or database studies utilizing electronic healthcare data, conducted by sponsors (as post marketing requirements or commitments, or voluntarily) or by government entities like the FDA’s BEST program and CDC’s Vaccine Safety Data Link. The process involves evaluating identified safety signals using all available data sources to determine if further regulatory action, such as label changes or other risk management measures, is necessary to ensure the safety of products for the US population, including pregnant individuals.